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Sponsors and Collaborators: |
Norwegian University of Science and Technology St. Olavs Hospital |
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Information provided by: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT00184106 |
We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their combination, (2) investigate the patterns of change and the mechanisms of action involved during treatment by using psycho-physiological assessments in order to delineate some of the cognitive, behavioural and physiological mechanisms in the patients’ response to CT, to paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be selected and randomised into four treatment conditions. The first group (N=25) will be treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo and clinical management (N=25). All patients will have 12 weeks of treatment in the acute phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The 4th group will have placebo for 24 weeks and clinical management. The patients will be assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12 weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months.
Measures are based on all three main sources; self-report inventories, clinical assessments by independent raters and psycho-physiological assessments.
Condition | Intervention | Phase |
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Phobic Disorders |
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Randomised, Triple Blind, Placebo-Controlled Trial Comparing the Effects of Cognitive Therapy, Paroxetine and Both Cognitive Therapy and Paroxetine in the Treatment of Patients With Primary Social Phobia |
Estimated Enrollment: | 100 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | July 2009 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hans M Nordahl, PhD | 73 59 82 92 | hans.nordahl@svt.ntnu.no |
Norway, Dragvoll | |
Dept. of Psychology, NTNU | Recruiting |
Trondheim, Dragvoll, Norway, 7491 | |
Contact: Hans M Nordahl, Professor + 47 72598292 hans.nordahl@svt.ntnu.no | |
Principal Investigator: Hans M Nordahl, Ph.D |
Principal Investigator: | Hans M Nordahl, Professor | Norwegian University of Science and Technology, NTNU |
Study ID Numbers: | SP/NTNU-2005 |
Study First Received: | September 9, 2005 |
Last Updated: | January 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00184106 |
Health Authority: | Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services |
Phobic disorders Therapy, cognitive Paroxetin |
Anxiety Disorders Mental Disorders Phobic Disorders Paroxetine Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Antidepressive Agents, Second-Generation Central Nervous System Agents Serotonin Uptake Inhibitors Antidepressive Agents Pharmacologic Actions |